Smartphone Application to Detect Skin Lesions

January 3, 2023 updated by: Beatrice Nardone, Northwestern University

Skin Lesion Detection With Novel Total Body Digital Photography Smartphone Application

The primary objective of Part One of this study is to determine the sensitivity of an automated total body digital photography (TBDP) app to detect color and size changes in the human skin, and whether a new lesion has arisen.

The primary objective of Part Two is to test the sensitivity and specificity as well as feasibility of field use of an automated TBDP app to detect pigmented and non-pigmented skin lesions in high risk populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SkinIO is an early-stage healthcare IT company specializing in education, early detection, and prevention of skin cancer. This study will utilize their product, skinIO, an enhanced full-body skin cancer screening system that works on mobile devices and tablets to track changes in skin over time without any additional imaging hardware. skinIO enables dermatology staff to photograph high-risk patients in 13 medical photography poses to quickly capture full-body skin surfaces at multiple resolutions using a mobile device. These images are automatically uploaded to a HIPAA-compliant server environment where they will be rapidly processed to detect any spots, lesions, and moles. Dermatologists will then be able to annotate these images and flag specific images for follow-up every month.

In order to assess whether or not the software will accurately detect spot changes, the investigators will test the product on a sample of volunteer subjects.

Part One:

The study population will undergo one study visit. This visit will include 2 sets of photos taken by the research team after the collection of a small amount of identifying and contact information for each subject. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings (ie. moles, angiomas, scars, keloids, seborrheic keratosis, small tattoos, etc). These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3- 5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. These markers have been AP certified to be non-toxic. The following colors have been chosen: orange, black, brown, red, blue, purple, yellow and pink. A second photograph will be taken of the same areas of the body chosen for initial photographs to determine if the application could detect the changes. This group will not have their images sent to a dermatologist for evaluation, as they are artificially produced.

Part Two:

In order to test the sensitivity and feasibility of field of use of the TBDP app, a second convenience sample of patients will be recruited. Recruitment will be done in waiting rooms with the attending physician's consent. If needed, recruitment will be done outside of the waiting room in the form of flyers, website and e-mail announcements. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. Each projection corresponds to each body area that will be photographed to ensure total body photography. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months. The patient will be provided a user guide with written instructions for application use. The TBDP app has a built-in reminder system for the patient. Any changes detected by the app will be stored on the research team's database. Standard of care will be followed for any new/changing lesions. Patients will be recommended to have a follow-up appointment with their dermatologist, within 2 weeks. No procedures will be completed by the research team, and a physician will not be seeing the patients during their research appointments. During these visits, the research team will compare the photographs taken by the TBDP app to the patient's skin to see how sensitive the app is. Patients will continue their regular office visits at 6 months and/or 12 months as per standard of care for high risk patients. The research team will use information from chart reviews for assessment of the outcome for new or changing lesions.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals with various skin types (Fitzpatrick I-IV)

Description

Inclusion Criteria:

  • Males and females age 18 - 85.

  • Subjects with the following skin types:

    1. Always burns, never tans or
    2. Burns easily, then develops light tan or
    3. Burns moderately, then develops light tan or
    4. Burns minimally rarely, then develops moderate tan.
  • Subjects who deny prior skin reactions to washable markers.
  • Subjects who have natural skin markings on at least 3 areas of their body.
  • Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator in English.
  • Subjects are able to complete the study procedures.
  • Subjects are willing to have digital photos taken of them.

Exclusion Criteria:

  • Subjects who have a history of skin disease (eg. vitiligo, psoriasis)

  • Subjects with the following skin types:

    1. Never burns, always develops a dark tan or
    2. Never burns, no noticeable change in appearance.

Part Two (only):

H] Subjects must be high risk. High risk is defined as subjects with conditions including, but not limited to: dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, immunosuppressed status I] Subjects must have an iPhone 4S or newer, or an iPad Air 2, iPad Mini 4 or iPad Pro in order to download and use the application and take photographs of high enough quality for the physician to analyze if needed.

J] Subjects must have someone who is able to take photos of the subject every month. The designated individual may or may not be present at the initial encounter.

4.2 Exclusion Criteria A] Subjects who have a history of skin disease (eg. vitiligo, psoriasis)

B] Subjects with the following skin types:

  1. Never burns, always develops a dark tan or
  2. Never burns, no noticeable change in appearance. Part Two (only) C] Subjects without the appropriate devices for app download. The appropriate devices are iPhone 4s or newer, or iPad Air 2, iPad Mini 4 or iPad Pro.

D] Subjects who do not have someone who is capable of taking photos of the subject every month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 Artificial Lesions
Photos will be taken of skin lesion markings using a smartphone
Other: Photos
Photos will be taken of skin lesion markings using a smart phone or tablet
Group 2 high risk
A convenience sample of patients will be recruited. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months.
Other: Photos
Photos will be taken of skin lesion markings using a smart phone or tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of an automated total body digital photography (TBDP)
Time Frame: Baseline
We will assess whether or not the photography software can accurately detect spot changes. We will test the product on a sample of volunteer subjects. The study population will undergo one study visit and will include 2 sets of photos. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings. These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3-5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. A second photograph will be taken of the same areas of the body chosen for the initial photographs in order to determine if the application could detect the changes.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of an automated total body digital photography (TBDP) in high risk subjects
Time Frame: Baseline, 6 and 12 months follow-up
Data will be compared between the last picture taken by the app before the clinic visit and the lesions seen by the clinician at the clinic visit. Total number of lesions will be those detected by the clinician, which were not present in the baseline skin evaluation.
Baseline, 6 and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Beatrice Nardone, MD, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

November 7, 2018

Study Completion (Actual)

September 2, 2022

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STU00202166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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